Diet and Stool Metabolites in Fecal Incontinence

April 13, 2018 updated by: University of Pennsylvania

Diet and Stool Metabolites in Women With Fecal Incontinence

Fecal Incontinence (FI) is a debilitating and common condition with a prevalence ranging from 7-15% in community dwelling women. FI has an immense impact on quality of life and is associated with increased care giver burden, increased rates of institutionalization, and significant cost burden in older women. Traditionally believed to be primarily caused by child birth injury, recent studies show that the typical age of onset of FI is age 40 which is remote from child birth. Treatment options for FI are limited because the mechanism underlying FI in older women are poorly understood. The overriding goal of this project is to investigate the relationship between diet, stool metabolites and fecal incontinence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Women with fecal incontinence from an outpatient GYN clinic.

Description

Inclusion Criteria:

  • Age greater than 18,
  • parous women with fecal incontinence (defined as any uncontrolled loss of liquid or solid fecal material that occurs at least monthly over the last 3 months that is bothersome enough to desire treatment),
  • current negative colon cancer screening

Exclusion Criteria:

  • Current bloody diarrhea,
  • current or past diagnosis of colorectal or anal malignancy,
  • diagnosis of inflammatory bowel disease,
  • recent antibiotic treatment,
  • history of immune deficiency diseases,
  • history of recent treatment with immune suppressant medications.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fecal incontinence
Women age >18 years old with a diagnosis of fecal incontinence
Other: No Intervention
No intervention
Controls
Women age >18 without a diangosis of fecal incontinence
Other: No Intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Stool butyrate levels
Time Frame: within 1 week of collection
within 1 week of collection
Pattern of dietary intake by indicator
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Stool levels of global metabolites
Time Frame: within 1 week of collection
within 1 week of collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 29, 2015

First Posted (Estimate)

June 30, 2015

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 13, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 822653

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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